MedTrace Logo

Investigation of the Two Level Simplify® Cervical Artificial Disc

NCT03123549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-01-08

Study results available
· View outcomes & findings →

Summary

This study is intended to demonstrate that the Simplify® Cervical Artificial Disc (Simplify® Disc) is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) when used to treat two contiguous discs from C3 to C7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with neck pain or myelopathy due to abnormalities localized to the levels of the two contiguous disc spaces in subjects who are unresponsive to conservative management.

Conditions

  • Cervical Degenerative Disc Disorder

Interventions

DEVICE

Simplify Disc

Simplify Disc at two levels of the cervical spine

Sponsors & Collaborators

  • NuVasive

    lead INDUSTRY

Principal Investigators

  • Kyle Malone · NuVasive

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2020-11-12
Completion
2022-03-24
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03123549 on ClinicalTrials.gov